PregabalinPhase 4NCT05640453
Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting
A Phase 4 study testing Pregabalin and Dexmedetomidine in people with Pregabalin and Delirium Treatment, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to determine the effect of pregabalin versus dexmedetomidine on the treatment and lasting duration of delirium in fast tracking elderly patients after Coronary Artery Bypass Grafting. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pregabalin, Delirium Treatment, Coronary Artery Bypass Grafting
- What is being tested?
- Pregabalin and Dexmedetomidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 15 May 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- CABG patients ≥ 65 years of age both genders American Society of Anesthesiologists (ASA) physical status classification II or III planned for fast track developed postoperative delirium (POD).
Who cannot join
- Patients who had history of psychiatric diseases; inability to communicate;
- previous history of POD; preoperative sick sinus syndrome, allergy/sensitivity to pregabalin or dexmedetomidine, severe bradycardia (heart rate <50 beat per minute), second-degree or above atrioventricular block without pacemaker; severe hepatic or renal insufficiency.
- Previous cardiac or thoracic surgery, known diagnosis of depression or other major psychiatric diseases, cognitive impairment or inability to cooperate with the study, renal insufficiency, and history of substance abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Islam Morsy
Tanta, El-Gharbia Governorate
Islam Morsy, MD, 00201093387374 ext. 139, eslam.morsy@med.tanta.edu.eg
Mohammed S El Sharkawy, MD
About this study
Official title: Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting: A Randomized Double-Blind Trial
The aim of this study is to determine the effect of pregabalin versus dexmedetomidine on the treatment and lasting duration of delirium in fast tracking elderly patients after Coronary Artery Bypass Grafting.
Read the detailed description
Delirium is an acute brain disorder that involves changes in consciousness, attention, cognition, and perception.The incidence of postoperative delirium (POD) is high among patients undergoing cardiac surgery, ranging from 20 to 50%, and the risk is even higher in the elderly.
- Being tested
- Pregabalin, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Patients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube.
DexmedetomidineDrug
Patients will receive a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min)
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin group | Active comparator | Patients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube. Receives: Drug: Pregabalin |
| Dexmedetomidine group | Active comparator | Patients will receive a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min) followed by an infusion of 0.2 to 0.7 μg/h. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of delirium treatment
Assessment of delirium will be performed preoperatively and postoperatively at 12-h intervals or as needed according to the patient's condition using the confusion assessment method (CAM)
Measured: 24 hour postoperatively
Secondary outcomes (3)
Level of sedation
Sedation level will be assessed by using the Ramsey sedation scale.
Measured: 24 hour postoperatively
Incidence of weaning from mechanical ventilation
percent of patients who weaned from mechanical ventilation
Measured: 1 week postoperatively
Length of hospital stay
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start15 Dec 2022
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregabalinStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Morsy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640453
- Sponsor's protocol ID
- 35912/10/22
- Status last verified
- Apr 2025
- First submitted
- 28 Nov 2022
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will available upon reasonable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting: A Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT05640453
- Acronym / sponsor ID
- 35912/10/22
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the effect of pregabalin versus dexmedetomidine on the treatment and lasting duration of delirium in fast tracking elderly patients after Coronary Artery Bypass Grafting.
Detailed description
Delirium is an acute brain disorder that involves changes in consciousness, attention, cognition, and perception.The incidence of postoperative delirium (POD) is high among patients undergoing cardiac surgery, ranging from 20 to 50%, and the risk is even higher in the elderly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin group | Active comparator | Drug: PregabalinPatients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube. |
| Dexmedetomidine group | Active comparator | Drug: DexmedetomidinePatients will receive a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min) followed by an infusion of 0.2 to 0.7 μg/h. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- CABG patients ≥ 65 years of age both genders American Society of Anesthesiologists (ASA) physical status classification II or III planned for fast track developed postoperative delirium (POD).
Key exclusion criteria (3 listed)
- Patients who had history of psychiatric diseases; inability to communicate;
- previous history of POD; preoperative sick sinus syndrome, allergy/sensitivity to pregabalin or dexmedetomidine, severe bradycardia (heart rate <50 beat per minute), second-degree or above atrioventricular block without pacemaker; severe hepatic or renal insufficiency.
- Previous cardiac or thoracic surgery, known diagnosis of depression or other major psychiatric diseases, cognitive impairment or inability to cooperate with the study, renal insufficiency, and history of substance abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinPatients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube. | Drug | Pregabalin group |
| DexmedetomidinePatients will receive a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min) | Drug | Dexmedetomidine group |
Primary outcome
Percent of delirium treatment
Time frame: 24 hour postoperatively
Assessment of delirium will be performed preoperatively and postoperatively at 12-h intervals or as needed according to the patient's condition using the confusion assessment method (CAM)
3 secondary outcomes
Level of sedation
Time frame: 24 hour postoperatively
Incidence of weaning from mechanical ventilation
Time frame: 1 week postoperatively
Length of hospital stay
Time frame: 1 month postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Yes. The data will available upon reasonable request from the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin and Dexmedetomidine in people with Pregabalin and Delirium Treatment, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Islam Morsy, MD (00201093387374, eslam.morsy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of delirium treatment (time frame: 24 hour postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.